Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer

The study aims to evaluate the safety and benefits of using indocyanine green in lymph node dissection for gastric cancer surgery. The primary endpoint is the average number of lymph nodes removed. Secondary study points are the average number of ICG-positive lymph nodes; the average number of metastatic ICG-positive lymph nodes; the number of postoperative complications and complications associated with the administration of ICG. Patients who meet the inclusion criteria for this study will be enrolled in the study after reviewing and signing an informed consent form. All patients will be included in one group and will receive surgical treatment in the amount of total or subtotal gastrectomy with lymphadenectomy D1, D1+, D2 or D2+. ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention. Assessment of the number of fluorescent lymph nodes will be performed intraoperatively with their subsequent removal and mapping. The incidence of postoperative complications will be assessed by Clavien-Dindo.

NCT Number	NCT06755554
Lead Sponsor	Ukrainian Society of Clinical Oncology
Conditions	Gastric Cancer Stage II, Gastric Cancer Stage III, Gastric Cancer, Gastrectomy for Gastric Cancer
Enrollment	105 participants
Start Date	2025-01-01
Primary Completion	2026-01-01 (estimated)
Study Completion	2026-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-30